ClinicalTrials.gg
RecruitingNCT02014389Updated Apr 25, 2024

Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

An observational study in Retinal Dystrophies, Retinitis Pigmentosa and Glaucoma, sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-25.

Primary conditionRetinitis PigmentosaRegistry: Retinal DystrophiesReclassifiedWhy we changed it
Registry
Retinal Dystrophies — the first condition term the registry derived for this study.
ClinicalTrials.gg
Retinitis Pigmentosa
Why
  1. The study's listed conditions name Retinitis Pigmentosa, a narrower term within Retinal Dystrophies.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sheba Medical Center · Observational

From the registry’s dates

  • Started Dec 2013; still recruiting 12 years 11 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Retinitis Pigmentosa with a site in Israel — 5 open to participants now, 9 under way, 1 of them phase 3. Retinitis Pigmentosa · Israel.

Started
2013
the only one that year
Observational
6 of 14
3 open now
Registered
5th of 14
by date
Lead sponsor
6 of 14
Sheba Medical Center

Among the 14 studies in Retinitis Pigmentosa with a site in Israel, this one is the only one that started in 2013, is one of 6 observational ones, and was the 5th registered.

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

Browse Retinitis Pigmentosa studies →

Open to participants now

5 of the 14 studies in Retinitis Pigmentosa with a site in Israel are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 49 Retinitis Pigmentosa studies recruiting now, 37 (76%) set no upper age limit and 7 (14%) stop at 75 or younger; 16 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Retinitis Pigmentosa with a site in Israel, or all of them as a file.
02

Study summary

Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.

Read the detailed description

Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.

A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field

03

Conditions studied

  • Retinal Dystrophies
  • Retinitis Pigmentosa
  • Glaucoma

Browse trials for

Keywords

  • Retinal Dystrophies
  • Retinitis Pigmentosa
  • Glaucoma
  • Visual Field
04

In context

Retinitis Pigmentosa Reclassified

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

This study's planned enrollment of 200 is above the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Compared within Retinitis Pigmentosa, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Retinal Dystrophies. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Two Groups: 1. Control, 2. Patients - Glaucoma patients with early damage (nasal step) of Humphrey visual field (HVF), Glaucoma patients with advanced damage of HVF (arcuate , tubular vision) and retinal dystrophy patientsl

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-80 years old.
  • Signing .
  • Pupillary reflex to light.

Exclusion criteria

Exclusion Criteria:

  1. Cloudy corneas.
  2. Surgical intraocular ophthalmic procedure within the past 30 days.
  3. No reactive pupils.
  4. Synechia of the iris to the lens after surgery or inflammation.
  5. Neovascularization.
  6. Axenfeld-Rieger Syndrome.
  7. Iris atrophy (ICE syndrome).
  8. Iris coloboma.
  9. Sphincter damage due to ischemia.
  10. Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
  11. Sphincter damage due to Herpes Zoster Uveitis.
  12. Sphincter damage due to high intraocular pressure.
  13. Iris tumor or cyst.
  14. Ectropion uvae.
  15. Adie's pupil.
  16. Third nerve aberrant regeneration of the iris sphincter.
  17. RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).
  18. Chronic use of myotics or mydriatics.
  19. Systemic medication that have affect on pupillary reflex .
  20. Any condition preventing accurate measurement or examination of the pupil.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy subjects

    Healthy subjects will be used as control group

  • Patients

    Patients with Glaucoma , Patients with retinal dystrophy

07

What researchers measure

Primary outcomes

  1. PLR response amplitude and latency

    Time frame: single visit

08

Study locations

1 of 1 sites recruiting
09

References and documents

Publications

  • Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127. PubMed 23482470 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2013 (actual). Primary completion is estimated for Dec 2026, 156 months after the start.

Of 48 observational studies under Retinitis Pigmentosa, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 28. This study's planned 156 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2013
First posted
Dec 18, 2013
StartActual
Dec 1, 2013
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Apr 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02014389
Responsible party
Dr. Ygal Rotenstreich (Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute, Sheba Medical Center) — Principal investigator
First posted
Dec 18, 2013
Start date
Dec 1, 2013
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 25, 2024

Study contacts

Ygal Rotenstreich, MD
Contact
Ygal.Rotenstreich@sheba.health.gov.il
972547898137

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion